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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 2119

Merck KGaA, Darmstadt, Germany and its affiliated companies

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
Food Contact Substance: Tin (IV) oxide (CAS Reg. No. 18282-10-5). REPLACES FCN 431
Notifier: Merck KGaA, Darmstadt, Germany and its affiliated companies
Manufacturer/Supplier: Merck KGaA, Darmstadt, Germany and its affiliated companies
Intended Use: For use in combination with titanium dioxide as a component of inorganic pigments. The pigment containing the FCS will be used as a colorant for food-contact polymers, coatings, paper and paperboard and in printing inks applied to non-food-contact surfaces of food-contact articles. Inorganic pigments containing the FCS are not intended for use in contact with infant formula and human milk (see Limitations/ Specifications).
Limitations/Specifications: For use at levels up to 12% of the total inorganic pigment weight. The finished food-contact articles containing the FCS may contact all food types under Conditions of Use A through H, and J. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Apr 27, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 75 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 112 kB)

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